YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 384 drug applications between 20 October 2026 and 26 October 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 60, covering 46 drug names.
2026/10/20 – 2026/10/26
- New acceptances this week
- 384
- Drugs with new generic filings (by drug name, de-duplicated)
- 46
- Accepted this week, now under review
- 361
DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.
Names with a public page are linked.
New acceptances this week
By application type and drug type
384filings, 60 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 228 |
| Generic | 60 |
| New drug | 51 |
| Import | 31 |
| Import re-registration | 9 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 187 |
| TCM | 121 |
| Therapeutic biologic | 67 |
| Biologic | 6 |
| Prophylactic biologic | 2 |
| In vitro diagnostic reagent | 1 |
DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.
Most new generic filings, by drug
46 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sodium Hyaluronate Eye Drops | 3 | 2 | 30 |
| 2 | Ruxolitinib Phosphate Tablets | 3 | 1 | 27 |
| 3 | Suvorexant Tablets | 3 | 1 | 3 |
| 4 | Acetylcysteine Oral Solution | 2 | 1 | 11 |
| 5 | Dotinurad Tablets | 2 | 1 | 55 |
| 6 | 环硅酸锆钠散 · No verified English name | 2 | 1 | 12 |
| 7 | 苯磺酸美洛加巴林口崩片 · No verified English name | 2 | 1 | 2 |
| 8 | 西诺氨酯片 · No verified English name | 2 | 1 | 24 |
| 9 | Dapagliflozin Tablets | 2 | 1 | 84 |
| 10 | Dalteparin Sodium Injection | 2 | 1 | 2 |
DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.
Most new acceptances, by company
258 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hunan Dong Jian Pharma Co., Ltd. romanized | 8 | 8 | 0 |
| 2 | AbbVie Inc. | 6 | 4 | 0 |
| 3 | Merck Europe B.V. | 5 | 3 | 0 |
| 4 | Medice Arzneimittel Pütter GmbH & Co. KG | 5 | 1 | 0 |
| 5 | Guangxi Wan Tong Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Shan Tou Shi Shi Dai Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 4 | 4 | 0 |
| 8 | Janssen-Cilag International NV | 4 | 3 | 0 |
| 9 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 4 | 3 | 0 |
| 10 | Topfond Pharmaceutical Co., Ltd. | 4 | 3 | 2 |
DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.
Under-review list changes
Compared across this platform's snapshots of the under-review list
- Entered review this week
- 149
- Left the under-review list this week
- 425
Of these, NMPA published approval-document delivery for 180 (including 167 supplemental applications, not counted as new marketing approvals) and notification delivery for 11; the outcome of the other 234 is to be checked.
Data collected since 2026/10/22: this week counts snapshots from 2026/10/23 only.
Most filings leaving review, by company
| # | Company (first applicant) | Filings | Drugs |
|---|---|---|---|
| 1 | F. Hoffmann-La Roche Ltd | 13 | 3 |
| 2 | Eli Lilly and Company | 12 | 3 |
| 3 | AstraZeneca AB | 11 | 5 |
| 4 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 8 | 3 |
| 5 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 7 | 4 |
| 6 | Novo Nordisk A/S | 7 | 3 |
| 7 | Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized | 6 | 2 |
| 8 | Ning Kang Rui Zhu Biopharmaceutical (Zhuhai) Co., Ltd. romanized | 6 | 2 |
| 9 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized | 6 | 1 |
| 10 | Novartis Pharma AG | 5 | 4 |
Most filings entering review, by company
| # | Company (first applicant) | Filings | Drugs |
|---|---|---|---|
| 1 | Guangxi Wan Tong Pharmaceutical Co., Ltd. romanized | 4 | 4 |
| 2 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 4 | 4 |
| 3 | Novo Nordisk A/S | 4 | 2 |
| 4 | Zhejiang Er Ying Medicines Co., Ltd. romanized | 3 | 1 |
| 5 | Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized | 3 | 1 |
| 6 | Zuo Jin Ming Pharmaceutical Co., Ltd. romanized | 2 | 2 |
| 7 | Beijing Mian Yi Fang Zhou Pharmaceuticals Technology Co., Ltd. romanized | 2 | 2 |
| 8 | Hua Run Shuang He Xiang Zhong Pharma (Hunan) Co., Ltd. romanized | 2 | 2 |
| 9 | Jilin Ji Chun Pharmaceutical Co., Ltd. romanized | 2 | 2 |
| 10 | Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | 2 | 2 |
DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
90 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/10/26Import · Class 1 | ABBV-901注射用粉末 · No verified English nameJXSL2600285 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2026/10/26Import · Class 1 | Azenosertib片 · No verified English nameJXHL2600463 | K-Group Beta Inc.; Hangzhou Tigermed Consulting Co. Ltd. |
| 2026/10/26Import · Class 1 | Azenosertib片 · No verified English nameJXHL2600462 | K-Group Beta Inc.; Hangzhou Tigermed Consulting Co. Ltd. |
| 2026/10/26Import · Class 2.4 | 注射用WCK 5222 · No verified English nameJXHL2600461 | Wockhardt Bio AG; Fortrea Pharmaceutical Research and Development (Beijing) Co. Ltd. |
| 2026/10/26Generic · Class 3 | 亚硒酸钠注射液 · No verified English nameCYHS2602625 | Ren He Yi Kang Hui Ze Pharma Hebei Co., Ltd. romanized |
| 2026/10/26Generic · Class 3 | 苯磺酸美洛加巴林口崩片 · No verified English nameCYHS2602617 | Topfond Pharmaceutical Co., Ltd. |
| 2026/10/26Generic · Class 3 | 苯磺酸美洛加巴林口崩片 · No verified English nameCYHS2602616 | Topfond Pharmaceutical Co., Ltd. |
| 2026/10/26Generic · Class 3 | Suvorexant TabletsCYHL2600124 | Guangdong Hao Rui En Pharmaceutical Co., Ltd. romanized |
| 2026/10/26Generic · Class 3 | Suvorexant TabletsCYHL2600123 | Guangdong Hao Rui En Pharmaceutical Co., Ltd. romanized |
| 2026/10/26Generic · Class 3 | Suvorexant TabletsCYHL2600122 | Guangdong Hao Rui En Pharmaceutical Co., Ltd. romanized |
| 2026/10/26New drug · Class 2.3 | 黄葵胶囊 · No verified English nameCXZL2600108 | Su Zhong Pharma Group Co., Ltd. romanized |
| 2026/10/26New drug · Class 2.2 | 信迪利单抗注射液 · No verified English nameCXSS2600170 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/10/26New drug · Class 1 | 诺吉仑赛注射液 · No verified English nameCXSS2600169 | Shanghai Jun Sai Bio Pharma Co., Ltd. romanized |
| 2026/10/26New drug · Class 1 | CM398注射液 · No verified English nameCXSL2601172 | Kang Nuo Ya Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/10/26New drug · Class 1 | SPGL008注射液 · No verified English nameCXSL2601171 | Shenzhen Sai Bao Er Bio Pharma Co., Ltd. romanized |
| 2026/10/26New drug · Class 1 | SSGJ-706注射液 · No verified English nameCXSL2601170 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2026/10/23Import · Class 2.2 | 萨特利珠单抗注射液 · No verified English nameJXSS2600098 | Roche Pharma (Schweiz) AG; Utsunomiya Plant of Chugai Pharma Manufacturing Co. Ltd.; Roche (China) Holding Ltd. |
| 2026/10/23Import · Class 1 | AZD0486 · No verified English nameJXSL2600284 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/10/23Import · Class 1 | AZD0486 · No verified English nameJXSL2600283 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/10/23Import · Class 1 | 注射用ABBV-969 · No verified English nameJXSL2600282 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2026/10/23Import · Class 1 | 579 - 痤疮 mRNA 注射液 · No verified English nameJXSL2600281 | Sanofi Vaccines US Inc.; Shenzhen Sanofi Biological Products Co. Ltd. |
| 2026/10/23Import · Class 2.4 | 甲苯磺酸利特昔替尼胶囊 · No verified English nameJXHS2600132 | Pfizer Inc.; Pfizer Manufacturing Deutschland GmbH; Pfizer Investment Co. Ltd. |
| 2026/10/23Import · Class 2.4 | 甲苯磺酸利特昔替尼胶囊 · No verified English nameJXHS2600131 | Pfizer Inc.; Pfizer Manufacturing Deutschland GmbH; Pfizer Investment Co. Ltd. |
| 2026/10/23Generic · Class 3 | Betahistine Dihydrochloride TabletsCYHS2602608 | Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd. |
| 2026/10/23Generic · Class 3 | 双氯芬酸依泊胺凝胶贴膏 · No verified English nameCYHL2600121 | Hangzhou Duan Ben Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/10/23New drug · Class 1.1 | 逍遥静音颗粒 · No verified English nameCXZL2600107 | Beijing Xin Rui Yuan Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/10/23New drug · Class 2.2 | 注射用伦康依隆妥单抗 · No verified English nameCXSS2600168 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Name not romanized |
| 2026/10/23New drug · Class 1 | 泰利奇拜单抗注射液(皮下注射) · No verified English nameCXSS2600167 | Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized |
| 2026/10/23New drug · Class 1 | IMM040811注射液 · No verified English nameCXSL2601169 | Beijing Mian Yi Fang Zhou Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/10/23New drug · Class 1 | IMM092注射液 · No verified English nameCXSL2601168 | Beijing Mian Yi Fang Zhou Pharmaceuticals Technology Co., Ltd. romanized |
60 more not listed (at most 30 rows).
DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.